Principal Regulatory Affairs Specialist
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The Principal Regulatory Affairs (RA) Specialist, will manage and lead regulatory submissions and develop regulatory strategies for investigational and marketed products by interacting effectively within a cross-functional project team of internal and external subject matter experts. The scope of regulatory submissions will focus on CMC and will also include clinical and non-clinical submission. This position serves as the regulatory representative on relevant project teams and as the regulatory contact with health authorities.
- Actively understand and interpret industry trends and health authority's expectations in areas related to CMC, non-clinical and clinical. Influence and communicate how these trends align with strategic department direction and vision.
- Develop regulatory strategy for CMC, non-clinical, and clinical and define the corresponding submission deliverables for assigned development projects or programs and for post- approval changes and ensure implementation of agreed upon strategies.
- Provide technical and strategic direction on CMC, non-clinical and clinical issues throughout product development and commercialization.
- Monitor changes to development plans and provide regulatory guidance to teams
- Represent Regulatory Affairs at various project team and working group meetings.
- Act as a direct point of contact with FDA and participate in meetings for CMC, non-clinical and clinical issues.
- Collaborate with equivalent cross-functional colleagues concerning CMC, non-clinical and clinical interests to meet project milestones.
- Lead in regulatory due diligence activities as assigned.
- Act as a direct point of contact with FDA and participate in meetings for CMC, non-clinical and clinical related issues.
- Execute strategies to ensure rapid and timely approval of applications for new and marketed products.
- Maintain cross-functional awareness of and expertise in ICH, FDA and EU guidelines related to regulatory topics.
- Liaison with business partners on regulatory matters on assigned programs
- Collaborate with RA senior management to create and implement policies, processes, and procedures supporting the department goals and objectives.
Requirements:
A minimum of a Bachelor's degree in related science field and 9+ years of experience is required.
An advanced degree is preferred (minimum 7+ years with MS, minimum 4+ years with PhD).
Must have regulatory experience in the pharmaceutical industry, with experience in a multi-project environment.
The candidate must have proven ability to lead and work effectively in cross-functional teams.
Minimum of 3+ years of demonstrated leadership skills.
Other Knowledge, Skills, and Abilities:
- 505 b2 and generic experience along with managerial experience is preferred.
- Experience with international health authorities is preferred.
- Extensive knowledge of US CMC regulatory requirements and the ability to apply knowledge both strategically and operationally to development projects and marketed product regulatory issues.
- Comprehensive knowledge of drug development process, pharmaceutical technology, drug manufacturing processes and related issues, drug laws, regulations and guidelines.
- Comprehensive knowledge and experience in CMC sections for investigational and marketed product submissions for FDA. Must have strong strategic and critical thinking, leadership, diplomacy and negotiation skills.
- Excellent written and verbal communications skills.
- Must be able to effectively communicate with scientists at all levels.
- Demonstrated ability to work in and lead effectively in matrix teams.
- Strong organization and time management skills.
- Demonstrated ability to influence based on experience, facts and data.